A Study to Evaluate the Antiviral Activity and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and Hepatitis D Co-infection

Sponsor

Huahui Health (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05674448

Collaborator

(none)

Enrollment

Location

Arms

16.8

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label phase IIa study of HH-003 to evaluate its antiviral activity and safety in subjects with chronic hepatitis B and hepatitis D co-infection. HH-003 is a human monoclonal antibody targeting the pre-S1 domain of the HBV large envelope protein. It blocks engagement of preS1 with sodium taurocholate co-transporting polypeptide (NTCP), the cellular receptor for HBV/HDV.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B and Hepatitis D Co-infection	Biological: HH-003 20mg/kg Biological: HH-003 3mg/kg	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label Phase IIa Study to Evaluate the Antiviral Effect and Safety of HH-003 Injection in Subjects With Chronic Hepatitis B and D Co-infection

Actual Study Start Date :

Aug 11, 2021

Actual Primary Completion Date :

Jul 25, 2022

Anticipated Study Completion Date :

Jan 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HH-003 20mg/kg HH-003 20mg/kg, intravenously, Q2W	Biological: HH-003 20mg/kg HH-003 20mg/kg Q2W intravenously for 24 weeks
Experimental: HH-003 3mg/kg HH-003 3mg/kg, intravenously, Q2W	Biological: HH-003 3mg/kg HH-003 3mg/kg Q2W intravenously for 24 weeks

Arm

Intervention/Treatment

Experimental: HH-003 20mg/kg

HH-003 20mg/kg, intravenously, Q2W

Biological: HH-003 20mg/kg

HH-003 20mg/kg Q2W intravenously for 24 weeks

Experimental: HH-003 3mg/kg

HH-003 3mg/kg, intravenously, Q2W

Biological: HH-003 3mg/kg

HH-003 3mg/kg Q2W intravenously for 24 weeks

Outcome Measures

Primary Outcome Measures

Percentage of Participants with HBV DNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24 [Week 24]
Percentage of Participants with HDV RNA Negativation or Decrease by ≥1 log10 from Baseline at Week 24 [Week 24]
Change from Baseline in Serum HBsAg Levels at Week 24 [from baseline to Week 24]

Secondary Outcome Measures

Percentage of participants with ALT normalization at week 24 [Week 24]
Changes from Baseline in Serum HBsAg Levels during the Study Period [from baseline to Week 48]
Changes from Baseline in Serum HBV RNA Levels during the Study Period [from baseline to Week 48]
Changes from Baseline in Serum HBV DNA Levels during the Study Period [from baseline to Week 48]
Changes from Baseline in Serum HDV RNA Levels during the Study Period [from baseline to Week 48]
Changes from Baseline in Serum HBeAg Levels in HBeAg-positive Subjects at Screening [from baseline to Week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent form;
Male or female subjects aged from 18 to 70 years inclusively;
18 kg/m2≤BMI≤32 kg/m2, body weight ≥45 kg for men and ≥40 kg for women;
Positive HBsAg, anti-HDV IgG antibody and HDV RNA at screening;
Women of childbearing potential or male subjects with female partners of childbearing potential should agree to use an adequate and highly effective contraceptions from screening to the end of study or until 12 weeks after last dose of the study drug (whichever is longer).

Exclusion Criteria:

Be pregnant or lactating at screening;
Subjects with decompensated liver cirrhosis;
Subjects with liver dysfunction (including but not limited to ascites, hepatic encephalopathy and upper gastrointestinal bleeding) within 3 months prior to screening;
Average daily alcohol consumption >40g for men and >20g for women or drug abuse within 6 months prior to screening;
Subjects with other serious diseases that is inappropriate for study participation per the Investigator's or the Sponsor's discretion (including but not limited to serious cardiac or pulmonary disease, chronic or recurrent urinary disorders, uncontrolled diabetes and autoimmune diseases, epilepsy requiring treatment);
History of hepatocellular carcinoma (HCC) or hepatocellular carcinoma suggested by liver histopathology or liver imaging;
Interferon antiviral therapy within 1 year prior to screening.